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Completed

NCT Number: NCT00692276

Investigating Superion™ In Spinal Stenosis

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Cardiovascular Diseases Intermittent Claudication Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Spinal Diseases Spinal Stenosis Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Center for Neurosurgery, Phoenix, Arizona, United States

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About this study

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects ≥ 45 years of age
  • Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
  • Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
  • Must be able to sit for 50 minutes without pain and to walk 50 feet or more

Exclusion criteria

  • Axial back pain only
  • Fixed motor deficit
  • Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
  • Unremitting pain in any spinal position
  • Significant peripheral neuropathy or acute denervation secondary to radiculopathy
  • Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
  • Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
  • Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
  • Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
  • Spondylolysis (pars fracture)
  • Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
  • Insulin-dependent diabetes mellitus
  • Prior surgery of the lumbar spine
  • Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
  • Infection in the disc or spine, past or present
  • Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
  • Tumor in the spine or a malignant tumor except for basal cell carcinoma
  • Involved in pending litigation of the spine or worker's compensation related to the back

Treatment and study plan

Superion™ Interspinous Spacer

Device

Implantation of interspinous process spacer to treat lumbar spinal stenosis

X-STOP® IPD® Device

Device

Implantation of interspinous process spacer to treat lumbar spinal stenosis

Primary outcomes

  1. Percentage of Subjects With Clinically Significant Improvement in Outcomes

    Time frame: Baseline and 24 months

    Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following:

    • At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains]
    • Improvement in physical function by ≥0.5 points
    • Improvement in symptom severity by ≥0.5 points
    • "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain
    • No re-operations, revisions, removals or supplemental fixation at the index level(s)
    • No major implant- or procedure-related complications:
    • No dislodgement, migration, or deformation
    • No new or persistent worsened neurological deficit at the index level
    • No spinous process fractures
    • No deep infection, death, or other permanent device attributed disability
    • No clinically significant confounding treatments:
    • No epidural injections or nerve block proc

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • VertiFlex, Incorporated

Registry information

Official study title

A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2008
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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